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What the label lists and what reports show

Polymyxin b side effects

Polymyxin b's FDA label lists its adverse reactions in its own words. FAERS holds 1,563 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pain (260 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the polymyxin b FDA label on DailyMed (effective May 9, 2025, Gland Pharma Limited); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

See WARNING box. Nephrotoxic reactions: Albuminuria, cylinduria, azotemia, and rising blood levels without any increase in dosage. Renal system reactions: Electrolyte and acid/base abnormalities (i.e., Pseudo-Bartter syndrome) Neurotoxic reactions: Facial flushing, dizziness progressing to ataxia, drowsiness, peripheral paresthesias (circumoral and stocking glove), apnea due to concurrent use of curariform muscle relaxants, other neurotoxic drugs or inadvertent overdosage, and signs of meningeal irritation with intrathecal administration, e.g., fever, headache, stiff neck and increased cell count and protein cerebrospinal fluid. Other reactions occasionally reported Drug fever, urticarial rash, pain (severe) at intramuscular injection sites, and thrombophlebitis at intravenous injection sites. …

Source: FDA drug label, Gland Pharma Limited, effective May 9, 2025 (SPL set dc74dee2-1d0b-4fab-a29b-1755fdb5da75), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,563 reports list polymyxin b among the medicines taken, each a report of something that happened, not proof the medicine caused it; 287 are coded as a death and 513 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)327
  • Pain260
  • Drug Hypersensitivity250
  • Malaise231
  • Pneumonia (a use or a product term, not a reaction)231
  • Vomiting200
  • Oedema186
  • Asthma185
  • Chest Pain180
  • Dyspnoea176
  • Macular Degeneration176
  • Nasal Oedema170
  • Respiratory Tract Infection165
  • Cough157
  • Wheezing157
  • Off Label Use (a use or a product term, not a reaction)140
  • Pyrexia105
  • Nausea85
  • Acute Kidney Injury80
  • Diarrhoea (named in the label)60
  • Anaemia56
  • Sepsis54
  • Weight Decreased51
  • Headache (named in the label)50
  • Infusion Related Reaction47

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Polymyxin b: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions